CONTACT: Sam Shull media@extheramedical.com

Proven treatment for critically ill patients is now available to federal organizations

MARTINEZ, Calif. – ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense. The contract grants streamlined access to the company’s Seraph^® 100 MicroBind^® Affinity Blood Filter. Military and VA clinicians have been enthusiastic users of Seraph 100 for the treatment of COVID-19.  News articles featuring Seraph 100 have been published by the Uniformed Services University and VA News.

“ExThera is proud to be contracted by the Federal Supply Schedule, working closely with federal agencies to expand access to the Seraph 100.  We have a growing body of evidence demonstrating lifesaving treatment for critically ill COVID-19 patients who often suffer from other ‘superinfections’ caused by bacteria and fungi,” said Robert Ward, Chairman, President and founder of ExThera Medical. 

To date, the Seraph 100 has received both European Union CE Mark under the Medical Device Directive and Emergency Use Authorization (EUA) to treat COVID-19 in the United States and Canada. 

“ExThera is committed to pursuing wider domestic and global access to its Seraph 100, to reach more patients, and provide treatment options to those who need them most.  The FSS contract is a major step in achieving that goal for the United States,” said Sam Shull, Chief Commercial Officer at ExThera Medical. 

Recent studies have demonstrated that the Seraph 100 quickly lowers the concentration of bacteria, viruses, and fungi, and most notably in critically ill patients suffering from SARS-CoV-2.  In addition, Seraph 100 has been shown to significantly reduce the bloodstream concentration of many drug-susceptible and drug-resistant pathogens, providing a long-awaited therapy that addresses the severe problem of drug-resistance along with new and future microbial threats like variants of the SARS-CoV-2 virus. 

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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. 

The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at http://www.extheramedical.com/.

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph^® 100 Microbind^® Affinity Filter (Seraph 100), it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 100 adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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